皮肤疾病临床研究选题和设计规范的理解

Outlook of topic selection and clinical research design standards for skin diseases

近年来,基于临床诊疗实践开展的皮肤病临床研究越来越受到广大皮肤科医疗和科研人员的重视和认可。如何基于皮肤科临床实践提出科学问题,如何通过规范的临床研究设计解决临床问题是驱动皮肤科临床诊疗水平不断提升的策源力。该文以临床研究选题为切入点,提出皮肤疾病临床研究选题的来源,指出研究设计时需遵从的代表性、真实性、可比性及显著性的指导思想,并基于临床研究PICO(patient,intervention,control,outcome)原则和临床试验报告统一标准,从皮肤疾病临床研究选题中所牵涉到的研究对象招募、样本量、对照设置、随机分组、盲法、干预方案实施、疗效评价、质量控制及统计分析等方面详细阐述皮肤疾病临床研究的设计规范和要点,以期为皮肤科临床研究的设计提供参考。

In recent years,clinical research on skin diseases based on clinical diagnosis and treatment practices has been increasingly valued and recognized by dermatology medical and scientific researchers.How to propose scientific questions based on clinical practice in dermatology,and how to solve clinical problems through standardized clinical research design are the driving forces for the continuous improvement of clinical diagnosis and treatment level of dermatology.This article took the selection of clinical research topics as the starting point,proposed the sources of clinical research topics for skin diseases,pointed out the guiding principles of representativeness,authenticity,comparability and significance that should be followed in research design,and elaborated the design norms and key points of clinical research on skin diseases from the aspects of patient recruitment,sample size,control setting,randomized grouping,blinding,intervention implementation,efficacy evaluation,quality control,and statistical analysis involved in the selection of clinical research topics,based on the principles of PICO(patient,intervention,control and outcome)and consolidated standards of reporting trials.To provide reference for the design of clinical research in dermatology.